Breast NeoplasmsPDONCT06468124
Sensitivity of Organoids to Predict Treatment Outcome in Breast Cancer Metastases
An observational study of Breast Neoplasms, run by King's College London at 2 sites in United Kingdom.
Trial summary
The aim of the study is to generate patient-derived organoids (PDOs) from brain resection or biopsied extra-cranial metastases. The preliminary data collected will be used to assess the ability of PDOs to predict patients' treatment response and their radio-sensitivity and chemo-sensitivity can be correlated with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- How many people
- 20 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 27 May 2025to 30 Jun 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients with resectable brain or extra-cranial metastases and undergoing postoperative radiotherapy or palliative radiotherapy to extracranial metastases if necessary +/- other systemic treatments after resection. Patients who will undergo a biopsy of the extra-cranial metastases may be recruited and asked to consent for an additional research biopsy at the same time as standard of care biopsy.
Who may be able to join
- Breast cancer patients with brain metastases who are suitable for surgical resection or Breast cancer patients with extra-cranial metastases undergoing surgical resection or biopsy
- Age > 18 years old
Who cannot join
- Patients unable to give informed consent e.g., mental disability or vulnerable adults
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Guy's and St. Thomas NHS Foundation Trust
London, SE1 9RT
Anthony Kong, 0207-848-8302, anthony.kong@kcl.ac.uk
Taylor McKenzie, 0207-848-8302, taylor.mckenzie@kcl.ac.uk
- Recruiting
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Keyoumars Ashkan, 02032993285, k.ashkan@nhs.net
Taylor McKenzie, taylor.mckenzie@kcl.ac.uk
About this study
Official title: Prospective Study to Correlate the Treatment Sensitivity of Patient-derived Organoids With Clinical Outcomes in Breast Cancer Patients With Brain and/or Extra-cranial Metastases
The aim of the study is to generate patient-derived organoids (PDOs) from brain resection or biopsied extra-cranial metastases. The preliminary data collected will be used to assess the ability of PDOs to predict patients' treatment response and their radio-sensitivity and chemo-sensitivity can be correlated with their survival outcome.
Read the detailed description
The SOTO-BC trail is an observation study and the patients will continue their clinical visits and follow-up as per normal standard of care.
Patient cohorts:
- Breast cancer patients with brain metastases undergoing surgical resection with or without further radiotherapy (SRS or whole brain radiotherapy)
- Breast cancer patients with extra-cranial metastases undergoing surgical resection or biopsy
Primary objective:
To assess the percentage of successful generated organoids from resected brain or resected/biopsied extra-cranial metastases of breast cancer patients
Secondary objectives:
- To assess the sensitivity of radiotherapy in PDOs
- To assess the sensitivity of the same systemic treatments that the patients previously had and will have in PDOs
- To correlate the treatment sensitivities of PDOs above with the treatment outcome of patients
- To correlate IC50 doses/dose response curves above with the objective response rates of patients undergoing same systemic treatment
Study Procedures:
Breast cancer patients with resectable brain or extra-cranial metastases or who will undergo a biopsy of the extra-cranial metastases will be asked to consent for this study and for their resected/biopsied samples to be used to generate PDOs. The investigators aim to recruit 20 patients in the pilot phase of the study.
When the PDOs contain sufficient cells, these cells will be treated with increasing doses of radiotherapy and/or relevant systemic treatments in order to determine the IC50 and to obtain dose-response curves of these PDOs to the treatments. The investigators will treat the PDOs with the same treatments that the patients had or will receive in order to correlate the responses to radiotherapy and/or systemic treatments including immunotherapy (co-cultured with immune cells).
The response of these PDOs will be compared to the treatment outcome and survivals in these patients.
- Conditions
- Breast Neoplasms
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients with brain metastases | Breast cancer patients with brain metastases undergoing surgical resection with or without further radiotherapy (SRS or whole brain radiotherapy) | |
| Breast cancer patients with extra-cranial metastases | Breast cancer patients with extra-cranial metastases undergoing surgical resection or biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient derived organoids
To generate PDOs from brain or extra-cranial metastases of breast cancer patients.
Measured: 10 months
Secondary outcomes (4)
Response to radiotherapy
To determine the dose response curves of radiotherapy
Measured: 6 months
Response to therapy
To determine the IC50 doses of the previous and same systemic treatments that patients had or will have in PDOs
Measured: 5 months
recurrence and survival rates
To correlate the IC50 doses and dose response curves above with the recurrence rates and progression-free survival of patients
Measured: 4 months
Response rate of patients undergoing systemic treatment
To correlate IC50 doses/dose response curves above with the objective response rates of patients undergoing same systemic treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start27 May 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Kong, Principal investigator, Clinical reader and honorary NHS consultant in clinical oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468124
- Sponsor's protocol ID
- 315793
- Acronym
- PDO
- Status last verified
- Dec 2025
- First submitted
- 4 Jun 2024
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Correlate the Treatment Sensitivity of Patient-derived Organoids With Clinical Outcomes in Breast Cancer Patients With Brain and/or Extra-cranial Metastases
- ClinicalTrials.gov ID
- NCT06468124
- Acronym / sponsor ID
- PDO / 315793
- Conditions
- Breast Neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 27 May 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to generate patient-derived organoids (PDOs) from brain resection or biopsied extra-cranial metastases. The preliminary data collected will be used to assess the ability of PDOs to predict patients' treatment response and their radio-sensitivity and chemo-sensitivity can be correlated with their survival outcome.
Detailed description
The SOTO-BC trail is an observation study and the patients will continue their clinical visits and follow-up as per normal standard of care.
Patient cohorts:
- Breast cancer patients with brain metastases undergoing surgical resection with or without further radiotherapy (SRS or whole brain radiotherapy)
- Breast cancer patients with extra-cranial metastases undergoing surgical resection or biopsy
Primary objective:
To assess the percentage of successful generated organoids from resected brain or resected/biopsied extra-cranial metastases of breast cancer patients
Secondary objectives:
- To assess the sensitivity of radiotherapy in PDOs
- To assess the sensitivity of the same systemic treatments that the patients previously had and will have in PDOs
- To correlate the treatment sensitivities of PDOs above with the treatment outcome of patients
- To correlate IC50 doses/dose response curves above with the objective response rates of patients undergoing same systemic treatment
Study Procedures:
Breast cancer patients with resectable brain or extra-cranial metastases or who will undergo a biopsy of the extra-cranial metastases will be asked to consent for this study and for their resected/biopsied samples to be used to generate PDOs. The investigators aim to recruit 20 patients in the pilot phase of the study.
When the PDOs contain sufficient cells, these cells will be treated with increasing doses of radiotherapy and/or relevant systemic treatments in order to determine the IC50 and to obtain dose-response curves of these PDOs to the treatments. The investigators will treat the PDOs with the same treatments that the patients had or will receive in order to correlate the responses to radiotherapy and/or systemic treatments including immunotherapy (co-cultured with immune cells).
The response of these PDOs will be compared to the treatment outcome and survivals in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients with brain metastases | – | –Breast cancer patients with brain metastases undergoing surgical resection with or without further radiotherapy (SRS or whole brain radiotherapy) |
| Breast cancer patients with extra-cranial metastases | – | –Breast cancer patients with extra-cranial metastases undergoing surgical resection or biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients with resectable brain or extra-cranial metastases and undergoing postoperative radiotherapy or palliative radiotherapy to extracranial metastases if necessary +/- other systemic treatments after resection. Patients who will undergo a biopsy of the extra-cranial metastases may be recruited and asked to consent for an additional research biopsy at the same time as standard of care biopsy.
Key inclusion criteria (2 listed)
- Breast cancer patients with brain metastases who are suitable for surgical resection or Breast cancer patients with extra-cranial metastases undergoing surgical resection or biopsy
- Age > 18 years old
Key exclusion criteria (1 listed)
- Patients unable to give informed consent e.g., mental disability or vulnerable adults
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient derived organoids
Time frame: 10 months
To generate PDOs from brain or extra-cranial metastases of breast cancer patients.
4 secondary outcomes
Response to radiotherapy
Time frame: 6 months
Response to therapy
Time frame: 5 months
recurrence and survival rates
Time frame: 4 months
Response rate of patients undergoing systemic treatment
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony Kong principal investigator
Clinical reader and honorary NHS consultant in clinical oncology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by King's College London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony Kong (0207 848 8302, Anthony.kong@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient derived organoids (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.